As we move into 2023, all of us at Oviya MedSafe take the pleasure of wishing you and your loved ones a very Happy & Prosperous New Year 2023 through this December 2022 edition of Oviya MedSafe’s newsletter (the 121st in the series since April 2012). The year 2022 was special for Oviya MedSafe as we got to celebrate our 10th anniversary as an organization and we would remain ever indebted to all of you for your goodwill for us.
Many of you in India may have noticed that something of Pharmacovigilance significance has happened at the end of 2022: India’s drug regulatory authority CDSCO (Central Drugs Standard Control Organization) has notified on 23rd Dec 2022 about inspections/audits of Pharmacovigilance systems of importers and manufacturers of human vaccines. While the notice speaks about the existing Pharmacovigilance regulatory requirements and indicates that inspections may be expected soon, the mention of vaccines in the title took all the limelight. However, a more important aspect of the same notice is that the industry stakeholders have been requested to share the following documents with the authority upfront at the earliest, which I believe is unprecedented:
- – Summary of established Pharmacovigilance system;
- – Name, e-mail address of Pharmacovigilance Officer In-Charge (PvOI) and name, address, contact person, and e-mail address of the premises where Pharmacovigilance system is established;
- – Self-inspection report (if any).
Regulatory experts in the industry observe that although only manufacturers and importers of human vaccines have been addressed in this notification, the regulations mentioned in support of the imminent inspections are common for all medicinal products and it will only be a matter of time before such requests are made to all license-holders. Further, on taking a closer look at the requested information, it is evident that a properly maintained Pharmacovigilance System Master File (PvMF in India) is the single most relevant comprehensive document that would provide all the details. One may argue that only a summary of the system has been requested but it must be remembered that CDSCO has every right to demand the complete PvMF soon after reviewing the summary document. Moreover, a summary document will be effective in terms of regulatory compliance only if a complete PvMF is already in place.
Oviya MedSafe, as you know, has been a pioneer in providing India-specific Pharmacovigilance services and we as an organization are keen to support you with our time-tested model of Instantly Integrated Pharmacovigilance Protection for the pharma/biotech/vaccine/consumer healthcare industries. By this unique model, we will be able to quickly deploy a regulatory-compliant Pharmacovigilance system by leveraging our readily available prototype and applying specific customizations as needed for each client of ours. With our rich and varied experience of working with wide range of clients in several parts of the world, Oviya MedSafe is well-positioned to help you fulfil your Pharmacovigilance obligations effectively. For more information, please feel free to contact us.
Before signing off, I wish to share with you about an event that I am involved in and an honour that I have been bestowed with, both being in my individual capacity. First, I will be moderating a panel discussion titled ‘Innovation as a Way of Life in Pharmacovigilance‘ at the 16th Annual Conference of ISCR (Indian Society for Clinical Research) which is to be held at Pullman Hotel, New Delhi from 23rd to 25th February 2023. To know more about the conference and register online, please visit this webpage. Second, I have been chosen by the Drug Information Association (DIA) as the Regional Editor for India of Global Forum, one of DIA’s official publications, for the 4th consecutive two-year term. I earnestly thank both ISCR and DIA for entrusting me with these responsibilities and I invite all of you to continue being my co-travelers in my pro-bono activities also.
Wishing you all Happy Pongal/Makar Sankranti/Lohri/Uttarayan/Magh Bihu and related festivities,
Waiting to meet you in our January 2023 newsletter,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Phone: +91 422 2444442
Oviya MedSafe UK Ltd,
Phone: +44 20 3393 6037